MONODOX Drug Patent Profile
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When do Monodox patents expire, and what generic alternatives are available?
Monodox is a drug marketed by Chartwell Rx and is included in one NDA.
The generic ingredient in MONODOX is doxycycline. There are twenty-eight drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the doxycycline profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Monodox
A generic version of MONODOX was approved as doxycycline by SUN PHARM INDS LTD on November 22nd, 2000.
Summary for MONODOX
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 123 |
Clinical Trials: | 7 |
Patent Applications: | 2,449 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for MONODOX |
What excipients (inactive ingredients) are in MONODOX? | MONODOX excipients list |
DailyMed Link: | MONODOX at DailyMed |
Recent Clinical Trials for MONODOX
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Washington | Phase 3 |
National Institute of Allergy and Infectious Diseases (NIAID) | Phase 3 |
Anapharm | Phase 1 |
Pharmacology for MONODOX
Drug Class | Tetracycline-class Drug |
Anatomical Therapeutic Chemical (ATC) Classes for MONODOX
US Patents and Regulatory Information for MONODOX
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Chartwell Rx | MONODOX | doxycycline | CAPSULE;ORAL | 050641-002 | Feb 10, 1992 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Chartwell Rx | MONODOX | doxycycline | CAPSULE;ORAL | 050641-004 | Feb 17, 2022 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Chartwell Rx | MONODOX | doxycycline | CAPSULE;ORAL | 050641-003 | Oct 18, 2006 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Chartwell Rx | MONODOX | doxycycline | CAPSULE;ORAL | 050641-001 | Dec 29, 1989 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for MONODOX
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Pfizer Limited | Doxirobe | Doxycycline | EMEA/V/C/000044 Treatment of periodontal disease in dogs.Periodontal pocket probing depths >=4 mm are evidence of disease that may be responsive to treatment with the Doxirobe Gel. Use of this product as directed should result in attachment level gains, periodontal pocket depth reductions, local antimicrobial effect and improved gingival health. Noticeable improvements in these parameters should be evident within 2-4 weeks following treatment. The response in individual dogs is dependent on the severity of the condition and rigor of adjunctive therapy. |
Withdrawn | no | no | no | 1999-09-16 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |